Busse Hospital Disposables
4.5MM SS Diamond Tip Trocar Tray with oversized Cannula and medium gloves
1manufacturer
62catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
Record
| Listed by | Robert Busse & Co., Inc., United States |
|---|---|
| FDA product code | FBQ |
| Device type | Trocar, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Premarket notification | Exempt |
| Record published | 2020-07-16 |
| Record revised | 2020-04-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Pack of 20, pack of 30, pack of 100, pack of 10, pack of 25, pack of 24 |
| Distribution end date | 2026-05-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B1354 | In distribution | |
| B1712 | In distribution | |
| B1144 | In distribution | |
| B2435 | In distribution | |
| B1717 | In distribution | |
| B8931 | In distribution | |
| B2381 | In distribution | |
| B2086 | In distribution | |
| B1559 | In distribution | |
| B8460 | In distribution | |
| B1715 | In distribution | |
| B2380 | In distribution | |
| B1716 | In distribution | |
| B2087 | In distribution | |
| B2599 | In distribution | |
| B9175R1 | In distribution | |
| B1713 | In distribution | |
| B1145 | In distribution | |
| B2379 | In distribution | |
| B2378 | In distribution | |
| B1118 | In distribution | |
| B1930 | In distribution | |
| B1954 | In distribution | |
| B8124 | In distribution | |
| B8462 | In distribution | |
| B1365 | In distribution | |
| B9179 | In distribution | |
| B7345 | In distribution | |
| 8786 | In distribution | |
| B1329 | In distribution | |
| B1714 | In distribution | |
| B8123R1 | In distribution | |
| B8108R1 | In distribution | |
| B6705 | In distribution | |
| B2560 | In distribution | |
| B8475 | In distribution | |
| B1120 | In distribution | |
| B8482 | In distribution | |
| B1146 | In distribution | |
| B9176R1 | In distribution | |
| B1568 | In distribution | |
| B3132 | In distribution | |
| B1324 | In distribution | |
| B1351 | In distribution | |
| B8461 | In distribution | |
| B2433 | In distribution | |
| B6819R1 | In distribution | |
| B1330 | In distribution | |
| B8473 | In distribution | |
| B8128R1 | In distribution | |
| B2089 | In distribution | |
| B8474 | In distribution | |
| B1570 | In distribution | |
| B9806 | Withdrawn | |
| B2312 | Withdrawn | |
| B2436 | Withdrawn | |
| B9803 | Withdrawn | |
| B9805 | Withdrawn | |
| B1328 | Withdrawn | |
| B1435 | Withdrawn | |
| B1360 | Withdrawn | |
| B1326 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Riwo-ART | Richard Wolf Gmbh | 52 |
| Trocar, Gastro-Urology | Richard Wolf Gmbh | 43 |
| Doctor Nice | B. ALI Impex | 23 |
| MIP Minimal Invasive Pcnl | Karl Storz GmbH & Co. KG | 6 |
| Spring Grip | Covidien LP | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Trotec | Richard Wolf Gmbh | 6 |
| Trocar, Gastro-Urology | Karl Storz GmbH & Co. KG | 5 |
| Cook | Cook Incorporated | 5 |
| EchoTip | Cook Incorporated | 3 |
| Strauss Surgical | American Medical Endoscopy | 3 |
| Mitty-Pollack | Cook Incorporated | 3 |
Showing 12 of 19. All products under Trocar, Gastro-Urology
Recalls Naming This Product
13 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 120 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 120 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 30 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 90 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 30 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 60 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 30 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 100 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 48 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 250 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 50 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 1040 units | 2024-04-17 |
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 360 units | 2024-04-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.